Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP)
- Registration Number
- NCT00763321
- Lead Sponsor
- AbbVie (prior sponsor, Abbott)
- Brief Summary
The primary purpose of the study is to test the efficacy of 2 tablets (twice daily) of ABT-712, compared to placebo, administered over a 4-week period in participants with moderate to severe mechanical chronic low back pain (CLBP).
- Detailed Description
The study used a randomized withdrawal design with an open label (OL) period prior to a double-blind (DB) period. Participants who were receiving benefit and were tolerating ABT-712 during the OL period were randomized into the DB period. Study drug was given for a total of 8 weeks, which included up to 3 weeks in OL, up to 4 weeks in DB, and a 1-week DB taper. During the OL period, all participants took increasing doses of ABT-712 until they were taking 2 tablets, twice daily. During the DB period, participants in the ABT-712 group took 2 ABT-712 tablets, twice daily throughout the 4 weeks, while participants in the placebo group took 2 placebo tablets twice daily.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 287
- Adult male and female subjects who voluntarily sign the informed consent
- Diagnosis of CLBP of 6 months duration
- Incapacitated or bedridden subjects
- Subjects with history of surgical or invasive intervention
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Open-label ABT-712 ABT-712 2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period). Double-blind ABT-712 ABT-712 2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period). Double-blind Placebo Placebo 2 placebo tablets, twice daily, for 4 weeks (double-blind period).
- Primary Outcome Measures
Name Time Method Change From Double-blind (DB) Baseline to Final Assessment in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS) Double-blind baseline to 4 weeks The change from the DB randomization baseline (DB baseline: the last assessment before first dose in the DB period) to the final assessment in pain intensity, assessed using the CLBP Intensity VAS (0 mm = No Pain and 100 mm = Worst Pain Imaginable). Least squares means and standard errors from 2-way ANCOVA model without interaction.
- Secondary Outcome Measures
Name Time Method Change From Double-blind (DB) Baseline to Final Assessment in Chronic Pain Sleep Inventory (CPSI) Double-blind baseline to 4 weeks The change from the DB randomization baseline (DB baseline: the last assessment before first dose in the DB period) to the final assessment of the impact of pain on the participant's sleep. The CPSI utilizes a 100 mm VAS scale for questions of how often the participant had trouble falling asleep because of pain, needed sleeping medication, was awakened by pain during the night, and was awakened by pain in the morning (0 mm = Never and 100 mm = Always); and for rating the overall quality of sleep (0 mm = Very Poor and 100 mm = Excellent). Least squares means and standard errors from 2-way ANCOVA model without interaction.
Trial Locations
- Locations (31)
Site Reference ID/Investigator# 10041
🇺🇸Pasadena, Maryland, United States
Site Reference ID/Investigator# 10062
🇺🇸Biloxi, Mississippi, United States
Site Reference ID/Investigator# 10066
🇺🇸Florissant, Missouri, United States
Site Reference ID/Investigator# 10075
🇺🇸Williamsville, New York, United States
Site Reference ID/Investigator# 10063
🇺🇸Greer, South Carolina, United States
Site Reference ID/Investigator# 10044
🇺🇸Huntsville, Alabama, United States
Site Reference ID/Investigator# 10060
🇺🇸Atlantis, Florida, United States
Site Reference ID/Investigator# 10067
🇺🇸Fargo, North Dakota, United States
Site Reference ID/Investigator# 10070
🇺🇸Burbank, California, United States
Site Reference ID/Investigator# 10054
🇺🇸Atlanta, Georgia, United States
Site Reference ID/Investigator# 10073
🇺🇸St. Louis, Missouri, United States
Site Reference ID/Investigator# 10043
🇺🇸Valparaiso, Indiana, United States
Site Reference ID/Investigator# 10072
🇺🇸Prairie Village, Kansas, United States
Site Reference ID/Investigator# 10048
🇺🇸Chesapeake, Virginia, United States
Site Reference ID/Investigator# 10071
🇺🇸Marietta, Georgia, United States
Site Reference ID/Investigator# 10059
🇺🇸Dallas, Texas, United States
Site Reference ID/Investigator# 10045
🇺🇸Kissimmee, Florida, United States
Site Reference ID/Investigator# 10055
🇺🇸Newburgh, Indiana, United States
Site Reference ID/Investigator# 10052
🇺🇸Altoona, Pennsylvania, United States
Site Reference ID/Investigator# 10069
🇺🇸Hollywood, Florida, United States
Site Reference ID/Investigator# 10053
🇺🇸Evansville, Indiana, United States
Site Reference ID/Investigator# 10049
🇺🇸Springfield, Massachusetts, United States
Site Reference ID/Investigator# 10058
🇺🇸Austin, Texas, United States
Site Reference ID/Investigator# 10042
🇺🇸Bridgeville, Pennsylvania, United States
Site Reference ID/Investigator# 10046
🇺🇸Austin, Texas, United States
Site Reference ID/Investigator# 13604
🇺🇸Chicago, Illinois, United States
Site Reference ID/Investigator# 10065
🇺🇸Winston-Salem, North Carolina, United States
Site Reference ID/Investigator# 10047
🇺🇸Oklahoma City, Oklahoma, United States
Site Reference ID/Investigator# 10050
🇺🇸San Diego, California, United States
Site Reference ID/Investigator# 10056
🇺🇸Omaha, Nebraska, United States
Site Reference ID/Investigator# 10061
🇺🇸Tampa, Florida, United States